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NCT Number: NCT04809506

Identification of New Biomarkers for the Prediction of Cardiovascular Events

The main goal of this project is to constitute a collection of biological samples, obtained through the clinical activity of the Centre for Screening and Prevention of Atherosclerosis at Toulouse University Hospital, managing patients in primary or secondary prevention for cardiovascular (CV) diseases. The main objective is to validate new biomarkers with prognostic value regarding the onset of future CV events. Besides, the biological collection will enable patho-physiological studies on atherosclerosis related diseases.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Toulouse

Toulouse, 31059, France

Location status: Recruiting

Location contact

Jean Ferrières, PU-PH

CONTACT

[email protected]

562323728 ext. 0033

About this study

Cardiovascular (CV) diseases, particularly those secondary to atherosclerosis, are a leading cause of morbidity and mortality in modern societies. Classical CV risk factors, including age and gender, family history, tobacco smoking, hypertension, diabetes, dyslipidemia and obesity cannot predict more than 50% of future CV events. Use of specific scores (like the SCORE chart) does not much contribute to the precise evaluation of patients classified at moderate risk. Thus, more research is needed: 1) to study patho-physiological mechanisms of the atherothrombotic process in order to identify new pharmacological targets and, 2) to validate new biomarkers with a strong predictive value regarding the onset of hard CV clinical events. Moreover, genetic polymorphisms underlie an individual's susceptibility to develop atherosclerotic diseases. Identification of those gene variants might help to define a personalized approach for the treatment of CV diseases. Patients consulting the Centre for Screening and Prevention of Atherosclerosis (CDPA) are submitted to a personal face-to-face interview addressing their life style, nutritional and smoking habits, and their physical activity practice. Clinical examination includes ECG, stress test, ankle-arm systolic index, ultrasonography of arteries (carotid, aorta, lower limb) and determination of a coronary calcification score. Blood samples are taken up for chemistry measurements including lipoproteins (triglycerides, LDL-C, HDL-C, Lp(a)). For the specific purpose of the biological collection, two supplementary blood tubes will be collected (2 x 7 ml); serum, plasma and genomic DNA will be prepared. Patients will be followed up yearly for those on secondary prevention and every 2nd year on primary prevention. Identical investigation will be carried out at every visit. Recruitment period will spread over 5 years and follow-up will be pursued up to 8 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults over 18 yrs;
  • consulting the Centre for Screening and Prevention of Atherosclerosis (CDPA) for management of their cardiovascular risk factors;
  • patients on primary prevention, free of personal history of coronary artery disease, stroke or lower limb arteriopathy, or patients on secondary prevention having presented one of the above mentioned diseases;
  • patients affiliated to a health insurance system;
  • patients having given their written informed consent for a participation to the study and for possible genetic analysis of their personal traits.

Exclusion criteria

  • Patients under the age of 18;
  • patients being under legal protection

Treatment and study plan

additional blood samples

Biological

2 additional blood samples (2 x 7ml) at every visit

Primary outcomes

  1. measurement of the candidate biomarker

    Time frame: Day 0

    measurement, at baseline of the candidate biomarker, with respect to the onset, during follow-up, of a cardiovascular event: either coronary events or cerebrovascular stroke or lower limb arteriopathy.

  2. measurement of the candidate biomarker

    Time frame: during the intervention/procedure/surgery

    measurement, at baseline of the candidate biomarker, with respect to the onset, during follow-up, of a cardiovascular event: either coronary events or cerebrovascular stroke or lower limb arteriopathy.

Secondary outcomes

  1. evolution of clinical and biological parameters involved in atherothrombosis

    Time frame: Day 0

    Pathophysiological mechanisms involved in atherothrombosis will be investigated using biomarkers addressing specific pathways: lipid metabolism, inflammation, endothelial reactivity, myocardial function. For a given new biomarker, its transferability to a clinical lab will be evaluated by its analytical performances and its possible adaptation to a semi-automated platform.

  2. evolution of clinical and biological parameters involved in atherothrombosis

    Time frame: during the intervention/procedure/surgery

    Pathophysiological mechanisms involved in atherothrombosis will be investigated using biomarkers addressing specific pathways: lipid metabolism, inflammation, endothelial reactivity, myocardial function. For a given new biomarker, its transferability to a clinical lab will be evaluated by its analytical performances and its possible adaptation to a semi-automated platform.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean Ferrières, MD PhD

CONTACT

[email protected]

562323728 ext. 0033

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Bio-collection for the Discovery of New Biomarkers for the Prediction of Cardiovascular Events

Acronym: CDPA-Biobank

Important dates

Study start
2021
Primary completion
2030
Study completion
2034
First posted
Mar 22, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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